Director Clinical Research

Bracco Imaging S.p.A.; Princeton (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Bracco Imaging S.p.A. seeks a strategic Director, Clinical Research to lead and manage clinical programs from design to execution. You will partner with internal stakeholders, CROs and investigators to ensure timely, compliant delivery of studies.

Education includes a life sciences degree and 10+ years in clinical research with multinational experience. Strong leadership, communication and project management skills are essential.

Qualifications

• 10+ years in Clinical Research/Management with multinational/multi-site exposure.
• Strong organizational, communication and teamwork skills.
• Experience in diagnostic imaging field is desirable.

Responsibilities

• Lead and oversee clinical research programs and multiple studies.
• Author and finalize study protocols for interventional, non-interventional and retrospective studies.
• Identify and qualify investigational sites.
• Manage CROs, vendors, and clinical study staff.
• Ensure compliance with ICH/GCP and regulatory requirements.
• Coordinate investigator meetings and site training.
• Oversee safety reporting, including SUSAR submissions.

Skills

Clinical Research Management

Multisite trials coordination

Regulatory/GCP knowledge

Cross-functional leadership

Project prioritization

Communication skills

Independent work

Team collaboration

Education

B.S./B.A. in Life Sciences

Job description

We are seeking a strategic and results-driven Director, Clinical Research to lead and manage clinical research programs from design through execution. This role is responsible for overseeing clinical studies, guiding cross-functional teams, and ensuring all research activities are conducted in compliance with regulatory standards and timelines. This leader will serve as a key partner to internal stakeholders, CROs, investigators, and vendors, ensuring high-quality execution and delivery of clinical programs.

Key Responsibilities

• Lead and oversee clinical research programs and multiple clinical studies
• Author and finalize study protocols for interventional, non-interventional, and retrospective studies
• Identify, select, and qualify investigational sites
• Manage and supervise CROs, vendors, consultants, and clinical study staff
• Ensure compliance with ICH/GCP guidelines and applicable regulatory requirements
• Conduct or oversee site visits and monitoring activities as needed
• Review informed consent forms and maintain accurate Study Master File (TMF) documentation
• Plan, coordinate, and lead investigator meetings and site training sessions
• Oversee safety reporting processes, including adverse event training and SUSAR submissions
• Manage clinical data flow, including query resolution and CRF tracking
• Coordinate clinical supply logistics, including shipment, accountability, and returns
• Track patient enrollment and proactively resolve site or study issues
• Maintain and update Clinical Trial Management Systems (CTMS)
• Ensure proper documentation and filing in relevant systems (e.g., TMF, Expresso)
• Oversee study budgets, vendor payments, and investigator payments
• Review and approve vendor invoices and associated documentation
• Communicate critical study or personnel issues to senior leadership
• Contribute to the development, review, and training of clinical SOPs

Education

• B.S./B.A. degree preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Professional Experience, Knowledge & Technical Skills

• 10+ years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines
• Strong organizational, communication and teamwork skills. Ability to manage several projects simultaneously. Experience in diagnostic imaging field is desired.
• Ability to manage multiple projects/programs simultaneously
• Ability to manage investigators, consultants, vendors
• Excellent written and verbal communication skills with particular attention to communicating study information
• Taking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any task
• Ability to work independently, with minimum supervision
• Ability to work in a team
• Ability to deal with competing priorities, meet aggressive timelines within the assigned scope of the project

Core Relationships

• Medical Planning and Management
• Medical Affairs and Scientific Information